Theorem Clinical Research

Global News

Molecular Profiles, Xenogesis partner

Monday, August 4, 2014 01:57 PM

Molecular Profiles, a contract development and manufacturing organization (CDMO) subsidiary of Columbia Laboratories, and CRO XenoGesis are collaborating to support pharmaceutical and biotech drug developers during the preclinical and formulation development stage. Molecular Profiles' pharmaceutical development services will be supported by XenoGesis' experience in preclinical drug metabolism and pharmacokinetics (DMPK) to give clients a smarter route into formulation development and a better understanding of a compound's bioavailability.  

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The Pulse on Global Trials

Monday, August 4, 2014 07:00 AM

As innovations in global healthcare continue to be explored, there is a heightened urgency among industry professionals to understand the rules of clinical trial recruitment, how they vary by region and what they mean for using digital channels such as online advertising, search engine marketing and social media to engage prospective participants.

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The CenterWatch Monthly, August 2014

Friday, August 1, 2014 01:46 PM

Reality of costs and impact rain on Sunshine Act

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MGC Diagnostics completes acquisition of MediSoft

Friday, August 1, 2014 01:43 PM

MGC Diagnostics, a global medical technologies company, has completed its acquisition of MediSoft, a privately held manufacturer of cardiorespiratory diagnostic products based in Belgium.

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ACRO backs COMPETE Act to expand R&D tax credit

Thursday, July 31, 2014 02:07 PM

On the eve of Congress’ summer departure, an R&D tax credit bill called the COMPETE Act was introduced this morning that would make the R&D tax credit permanent, increase the credit rate to 25% of qualifying research investments and enable investors in small research companies to claim the credit.

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FDA expands approved use of Imbruvica for CLL

Thursday, July 31, 2014 01:55 PM

The FDA has expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a Breakthrough Therapy Designation for this use.

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Noxxon initiates study of Anti-Hepcidin Spiegelmer Lexaptepid Pegol

Thursday, July 31, 2014 01:52 PM

Noxxon Pharma, a biopharmaceutical company developing proprietary therapeutics called Spiegelmers, has treated the first patient with its anti-hepcidin Spiegelmer lexaptepid pegol (NOX-H94) in a phase IIa proof-of-concept clinical trial to treat erythropoietin (EPO) hyporesponsive anemia in dialysis patients.

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INC Research appoints Jan Schreur senior vice president, human resources

Thursday, July 31, 2014 01:22 PM

INC Research, a global phase I to IV CRO, has appointed Jan Schreur as the company's senior vice president, human resources. Schreur brings nearly 30 years of progressive human resources experience to the role, including senior leadership positions at global biopharmaceutical organizations.

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AstraZeneca to acquire Almirall’s respiratory franchise

Thursday, July 31, 2014 12:39 PM

Barcelona-based Almirall has entered an agreement to transfer its respiratory franchise to AstraZeneca for an initial consideration of $875 million on completion and up to $1.22 billion in development, launch and sales-related milestones. AZ also has agreed to make various sales-related payments.

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CDC awards Leidos $44 million contract

Thursday, July 31, 2014 12:37 PM

Leidos, a national security, health and engineering solutions company, was awarded a prime task order by the Centers for Disease Control and Prevention (CDC) to provide development, support and maintenance of the National Healthcare Safety Network (NHSN).

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CWWeekly

September 2

Roche's $8.3B InterMune buy continues its buying spree with 'bolt-on' deal, fueling record M&A activity

FDA action plan seeks to close gap in women and minority patient representation in clinical trials

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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